Biological E seeks nod for phase 3 trial of Corbevax as booster dose


New Delhi, Oct 12 (IANS): Pharma major Biological E has sought approval from drug regulator Drugs Controller General of India to conduct the phase-3 clinical trial of Covid vaccine Corbevax. The company has sought approval as a single booster dose for those fully vaccinated with Covishield or Covaxin vaccines.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) may discuss the matter in its next meeting.

The phase 2/3 clinical trials of Corbevax are underway and the results are likely to be declared this month.

Corbevax is based on a protein antigen technology that binds to the Angiotensin Converting Enzyme-2 (ACE2) receptor on the host cell membrane and facilitates virus entry. The body's own cells stimulate the immune system of the body to produce antibodies to protect against the infection.

Biological E. received DCGI approval for conducting Phase III Comparator Safety & Immunogenicity trial in adults after the Subject Expert Committee's review of Phase I and II clinical trials data last month. Additionally, Biological E.A also received approval to initiate the Phase II/III Study to evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of CORBEVAX in children and adolescents last month.

The pharma company has submitted the application seeking the nod from DCGA to conduct the phase-3 clinical study of Corbevax.

 

  

Top Stories


Leave a Comment

Title: Biological E seeks nod for phase 3 trial of Corbevax as booster dose



You have 2000 characters left.

Disclaimer:

Please write your correct name and email address. Kindly do not post any personal, abusive, defamatory, infringing, obscene, indecent, discriminatory or unlawful or similar comments. Daijiworld.com will not be responsible for any defamatory message posted under this article.

Please note that sending false messages to insult, defame, intimidate, mislead or deceive people or to intentionally cause public disorder is punishable under law. It is obligatory on Daijiworld to provide the IP address and other details of senders of such comments, to the authority concerned upon request.

Hence, sending offensive comments using daijiworld will be purely at your own risk, and in no way will Daijiworld.com be held responsible.